Since we recognize the instrumental role that quality holds to ensure the safety of our products, we have worked hard to build a strong quality system and team. All policies and procedures are designed to meet or exceed FDA requirements under 21 CFR 1271 and AATB Standards. Our Quality Assurance Program oversees quality event management, document control, record management, validation/qualification activities, quality/labeling/purchasing control, training, and reviews, approval, and release of donor records and batch records.
Quality is built into our critical processes and support activities to provide evidence and verification of compliance.Our experienced quality team works to ensure that the entire operation is in conformity with the FDA regulations, AATB standards, and internal procedures. The suitability and effectiveness of the quality system is routinely evaluated at defined intervals.